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A Phase I Study of ECO-4601 in Patients With Advanced Cancer

10 de julio de 2008 actualizado por: Thallion Pharmaceuticals

A Phase I, Dose Finding, Pharmacokinetic, and Safety Study of Continuous IV Infusion of ECO-4601 in Patients With Advanced Cancer Including an Extension Portion to Obtain Safety Data at the Highest Tolerable Dose

The purpose of this study was to determine the maximum tolerated dose (MTD) and the recommended dose for future studies of ECO-4601 administered as a continuous IV infusion for 14 days with 7 days recovery (21 day cycle) in patients with histologically confirmed solid tumors (high grade glioma, colorectal, lung, breast, ovarian, pancreatic and prostate). This study was also designed to determine the clinical pharmacokinetic profile, safety of multiple cycles of administration, and document the antitumor activity of ECO-4601.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Actual)

26

Fase

  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Quebec
      • Greenfield Park, Quebec, Canadá, J4V 2H1
        • Hopital Charles Lemoyne
      • Montreal, Quebec, Canadá, H3T 1E2
        • Sir Mortimer B. Davis Jewish General Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Informed about the study and consent to participate in the study
  • Clinically or radiologically documented advanced solid malignancy for which no standard therapy is available, or which has failed standard therapy
  • Patients with the following solid tumors: high grade glioma, colorectal, prostate, pancreatic, lung, ovarian and breast carcinoma
  • Age ≥ 18 years of age
  • ECOG ≤ 2
  • Laboratory hematology and biochemistry protocol test result abnormalities ≤ Grade 1, graded using NCI CTCAE version 3.0
  • Patients with no chemotherapy during the 4 weeks preceding patients' first dose of ECO-4601 (day 1, cycle 1)
  • No other anticancer treatment during the study
  • Patients can be receiving stable or decreasing dose of steroids within 2 weeks prior to patient's signature of the informed consent
  • Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre
  • Previous Therapy

    • Hormonal therapy: Patients may have had prior hormonal therapy provided it is discontinued upon ICF signature
    • Radiation: Patients may have had prior radiation therapy. Patients must have recovered from the acute toxic effects of radiotherapy
    • Previous surgery: Previous surgery is permitted provided that at least 2 weeks have elapsed between major surgery (non-biopsy) and ICF signature

Exclusion Criteria:

  • Patients with brain metastases
  • Unlikely to comply with protocol or difficulty to understand the purpose of the study
  • Life expectancy < 12 weeks
  • Clinically significant co-morbid disease, e.g. renal failure, ischemic vascular disease, uncontrolled seizure, dementia
  • Any patient with a potentially curable malignancy who has not yet received appropriate standard therapies
  • Anti seizure drugs known inducers of cytochrome P450
  • Documented HIV, active hepatitis B or C infections
  • Patients with active or uncontrolled infections or with serious illnesses or medical conditions, which would not permit the patient to be managed according to protocol
  • Pregnant or lactating women; both men and women enrolled on study should be using adequate birth control measures throughout the course of the study. Women of childbearing potential must have a negative serum or urine pregnancy test documented within 14 days prior to registration and at study start
  • Inability or refusal to practice contraception during therapy of ECO-4601, unless patient is surgically sterile or woman is postmenopausal for at least 2 years
  • Patients who have been treated with any investigational drug within 4 weeks of patient's signature of informed consent form, or who are receiving concurrent treatment with other experimental drugs or anti cancer therapy
  • Patients in whom a proper central line cannot be established
  • Concomitant therapy with therapeutic coumadin; patients can be transferred to low molecular weight heparin
  • Patients on low molecular weight heparin for < 2 weeks prior to ICF signature
  • Polysorbate 80 being a major constituent of ECO-4601 and known to cause hypotension, patients with uncontrolled hypotension will be excluded
  • Known hypersensitivity to farnesylated dibenzodiazepinone or any of the formulation components

Concomitant Therapy Permitted:

  • Patients may receive ongoing supportive and palliative care (eg: pain control) as clinically indicated throughout the study.
  • Patients can be treated with corticosteroids if medically needed
  • Usage of low molecular weight heparin is allowed
  • Anti seizure products are permitted provided they are not inducers of cytochrome P450.

Concomitant Therapy Not Permitted:

  • Other anticancer treatment
  • Other investigational therapy
  • Concomitant therapy with coumadin
  • Cytochrome enzyme inducing anti epileptics
  • G-CSF, GM-CSF and other growth factors may not be used as a substitute for a scheduled dose reduction; however they may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated at the discretion of the investigator. Use of erythropoietin is allowed if treatment has been initiated for ≥ 2 months. Use of growth factors must be documented on case report forms.
  • Hormonal therapy

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: ECO-4601
Continuous IV infusion for 14 days with 7 days recovery (21 day cycle)
Otros nombres:
  • TLN-4601

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Safety/tolerability of ECO-4601
Determination of MTD of ECO-4601
Determination of recommended dose for future studies of ECO-4601

Medidas de resultado secundarias

Medida de resultado
Pharmacokinetics of ECO-4601
Safety of multiple cycles of administration of ECO-4601
Documentation of ECO-4601 antitumor activity as per RECIST criteria

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Petr Kavan, MD, Ph.D., Sir Mortimer B. Davis - Jewish General Hospital
  • Investigador principal: Benoît Samson, MD, Hopital Charles Lemoyne
  • Silla de estudio: Gerald Batist, MD, Sir Mortimer B. Davis - Jewish General Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de febrero de 2006

Finalización primaria (Actual)

1 de agosto de 2007

Finalización del estudio (Actual)

1 de agosto de 2007

Fechas de registro del estudio

Enviado por primera vez

15 de junio de 2006

Primero enviado que cumplió con los criterios de control de calidad

16 de junio de 2006

Publicado por primera vez (Estimar)

20 de junio de 2006

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

15 de julio de 2008

Última actualización enviada que cumplió con los criterios de control de calidad

10 de julio de 2008

Última verificación

1 de julio de 2008

Más información

Términos relacionados con este estudio

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre ECO-4601

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